CLIENT CASE STUDY

Top pharma co.: Supporting one of the largest NDA submissions ever received by the FDA

Accenture manages the NDA submission process end-to-end in an aggressive time frame for a submission of this scale.

Overview

A global, top-tier pharmaceutical company required outsourcing support to manage a new drug application (NDA) submission—one of the largest ever filed with the U.S. Food and Drug Administration (FDA)—for its blood clotting and stroke reduction medicine. Accenture collaborated with the company over three years to manage the process end-to-end for the NDA.

Accenture augmented the client’s in-house resources, easing the impact of peak demand and providing both strategic and operational regulatory expertise to streamline the submission process. The team also implemented a regulatory information management platform to facilitate submission preparation and enhance communications with the client’s internal regulatory teams.

The massive submission encompassed more than 71,000 files, 66,000 PDF documents and 2,500 datasets. With Accenture’s help, the company completed the filing in compliance with eCTD standards in a timely manner and met its NDA submission goals.

Opportunity

A global, top-tier pharmaceutical company sought Accenture’s cost-effective assistance on one of the largest-ever submissions filed with the U.S. Food and Drug Administration (FDA). A successful submission was crucial to helping the company achieve its goal of diversifying its innovative product portfolio. The size and scope of the submission made the project too large to be managed internally within the required time frame. The company collaborated with Accenture to manage the new drug application (NDA) submission for its blood clotting and stroke reduction medicine. Accenture collaborated with the company over three years to manage the process end-to-end for the NDA submission.

Solution

Accenture augmented the client’s in-house resources, easing the impact during peak demand and providing both strategic and operational regulatory expertise to streamline the FDA submission process. This involved implementing a regulatory information management platform to facilitate submission preparation and enhance communications with the client’s internal regulatory teams. Accenture’s regulatory affairs specialists also provided ongoing strategic guidance on managing interaction with the FDA. The team submitted a voluminous range of files and documents in compliance with electronic common technical document (eCTD) standards.

Results

With Accenture’s help, the company completed the filing within an aggressive time frame for a submission of such a scale—and, crucially, met its NDA submission goals. The massive submission encompassed more than 71,000 files, 66,000 PDF documents, 20 million PDF pages, and 2,500 datasets with 44 million hyperlinks and 18 million bookmarks. The Accenture team also helped to review and remediate 85 related data packages as well as create reviewer guides to supplement the submission. The company is now one step closer to achieving its goal of building a diverse, innovative pharmaceutical portfolio that drives growth and improves patient outcomes.

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